Preclinical drug development is inherently risky, with only one medicine being approved for every 10–20 candidates tested. The need to manage many moving parts, combined with increasing costs and the pressure to hit key milestones, means keeping a preclinical program on track can be a daunting task. But all is not lost, there is one crucial piece of the puzzle that can give you the competitive edge – utilizing a CRO’s scientific, operational and regulatory expertise at the very beginning of the preclinical stage to help design and carve your project plan.
Successful program plans start with the end in mind. As soon as you’ve identified your intended mechanism of treatment, you should engage your preclinical CRO to develop a program. Typically, this is while you are finalizing lead candidate selection. While this may seem early, it is important for developing a plan that meets your budget and milestone timelines, while producing a robust IND or CTA data package. This is key for not only satisfying regulatory requirements, but also for forming part of your presentation if you are looking to out-license your compound to large pharma for clinical development.
Here, we explore how engaging a preclinical CRO earlier in drug development can help you to meet your milestones, navigate the regulatory pathway in the most efficient and effect way possible for your molecule, and come in on budget.1. Engaging a preclinical CRO during lead candidate selection can increase your chances of meeting drug development milestones
Developing your drug development plan with a preclinical CRO is crucial in making sure your program progresses as needed to meet your milestones. During the planning stage, the preclinical CRO should work with you to identify areas of risk and put measures in place to help overcome these before they become a problem. For instance, estimating the quantity of the test article needed for preclinical studies is the number one cause of delay biotech companies experience (according to a customer survey carried out by the Envigo team).
By working with a preclinical CRO in the developmental stages of planning, they can help you accurately estimate the quantities you need to complete your CTA- or IND-enabling program and factor in the lead time needed to manufacture the product. As it can take 6–8 months to manufacture a 1–10 kg batch of your test article, failing to account for this in your plan could have a significant impact on your timelines, causing you to miss development milestones.
Additionally, as part of the planning phase, the preclinical CRO should schedule in the studies your drug development program requires in accordance with your agreed delivery timelines. If you are engaging with multiple preclinical CROs for different parts of your drug development program, be sure to consider how delays can have a non-linear impact on your overall project timelines and consequent milestones. For example, if one CRO misses a deadline by a few weeks, you could miss your slot with the next and then be forced to wait months until they can reschedule your study.
To help eliminate this risk, make sure all preclinical CROs involved with your drug development program are clear in the timelines they can deliver. Alternatively, you could consider working with one CRO that can perform every aspect of your preclinical project, meaning you don’t have to allow additional time between vendors or the consequences of one organization missing their deadline. For the best results, we recommend engaging with an integrated preclinical CRO to plan and execute your drug development program. As they’ll have been part of the planning stage, they will know all of the background information and will be best placed to schedule studies to speed up the journey.
Key takeaway: Engage with preclinical CROs early to explore the options available to you as you plan your drug development program. This will help to ensure your project has the best possible chances of hitting all your milestones.
2. A preclinical CRO will help you plan which studies you need to meet regulatory requirements
A strategic plan is essential for ensuring the greatest likelihood of a successful drug development program. When it comes to designing your IND-enabling GLP safety studies with a preclinical CRO, you need to think ahead to who your patients are and how the drug will be delivered. This is due to your preclinical safety program being built around the design and circumstances of your initial clinical trial, to ensure that the data provided by the program are sufficient to support approval of your CTA or IND application.
Experienced CROs can bring a wealth of expertise to your drug development plan and program. Having worked on thousands of projects previously, a preclinical CRO will be able to tell you which studies will need to be performed to secure regulatory approval, so you can start, and progress, through clinical development in accordance to the therapeutic indication and route of administration of your drug. The order in which these studies are undertaken may also vary depending on the requirements of your unique molecule, so it’s important to work with a preclinical CRO early in the planning phases of your drug development program to account for these nuances.
Engaging a preclinical CRO early in the planning phases of your drug development program will also ensure that you have the best data package possible to present to regulatory authorities. For example, in the United States, it is a requirement to attend a pre-IND meeting, where you are expected to present your preclinical safety program of work and any associated risks. At these meetings, common mistakes include only providing the bare minimum amount of information to regulators, which can ultimately result in your drug not being able to progress.
Key takeaway: Consult a preclinical CRO as early as possible in your drug development program, preferably during lead candidate selection, as they will be able to advise you of the necessary studies that need to be undertaken in order to produce a robust data package that will sate regulatory requirements.
3. Engage with a preclinical CRO early to increase your chances of coming in on budget
Carefully considered outsourcing is often a cost-effective approach to preclinical drug development, but how can you make sure that you get the best deal for your program? Consulting with a preclinical CRO early in drug development can give you a timely idea as to how much the program will cost. What’s more, by creating your development plan with an experienced preclinical CRO, you can be sure that you aren’t undertaking additional, unnecessary studies that waste precious funds and decrease your chances of coming in on budget.
As part of your planning, it's worth discussing with the preclinical CRO what additional costs could incur if your project happens to take longer than its allotted time. These costs will only be relevant if delays happen; however, by being aware of them from the beginning, you can plan your overall budget accordingly. So, if the worse were to happen, you would still be able to meet your financial targets.
By working closely with a CRO, you can quickly identify if the budget you’ve been given to complete the program is realistic. Although developing a comprehensive program budget with a preclinical CRO may increase planning time, it can save a lot of stress, money and resources in the long run. After all, it’s better to go to management with a detailed, considered breakdown before the project gets underway, rather than having to ask for more funds once the studies begin.
Once the program has started, having a detailed project plan that was agreed by the preclinical CRO and yourself will help to keep the program on track and greatly limit the chances of surprise costs creeping in. In this way, drug development project plans are invaluable when it comes to ensuring you don’t exceed your budgets.
Key takeaway: Involving a preclinical CRO in planning your drug development program and having open and honest discussions around budget can have a direct and positive impact on the overall program cost. So, the earlier you engage your preclinical CRO in the planning and budgeting stages of your drug development program, the better.
Planning a preclinical drug development program?
Engaging with a preclinical CRO as early as possible in development can significantly increase the likelihood of delivering a robust IND or CTA data package, on time and on budget. If you’d like to access more tips and advice on planning a successful drug development program, download our free e-book.